Enanta Reports Initiation of ABT-493 Phase 2B; Nymox Announces Positive Prostate Cancer Trial Results Print
By Staff and Wire Reports   
Wednesday, 10 September 2014 18:22
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 10, 2014.
Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA)
a research and development-focused
biotechnology company dedicated to creating small molecule drugs in the infectious disease field, announced AbbVie, Enanta's development partner for protease inhibitors for hepatitis C virus (HCV), has initiated a phase 2b clinical study with ABT-493, Enanta's next-generation protease inhibitor. ABT-493 is the second clinical-stage protease inhibitor candidate developed within the Enanta-AbbVie collaboration.

The phase 2b study being conducted by AbbVie will evaluate the safety and efficacy of ABT-493 co-administered with ABT-530, AbbVie's next generation NS5A inhibitor, in HCV patients. AbbVie has informed Enanta that results from this trial are expected in 2015 and AbbVie plans to start phase 3 development of the combination next year.

“The goal of our collaboration's next-generation protease inhibitor program is a pan-genotypic, ribavirin-free, once-daily dosing regimen for HCV patients,” stated Jay R. Luly, Ph.D., President and CEO.



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Nymox Pharmaceutical Corporation (Nasdaq: NYMX)
announced today new positive outcome results from the Company's ongoing prospective NX03-0040 trial of NX-1207 for the treatment of low grade localized prostate cancer. Clinical outcomes were determined at 8 months from the initial treatments. A controlled comparison was conducted of patients who required and received radiation and surgery treatments for their cancer based on blinded post-treatment upgraded evaluations of their pre-treatment initially positive lower grade cancers. The study found after 8 months for NX-1207 single-injection treated patients that  there was a statistically significant reduction compared to controls of more than 75% (p=.002) in the proportion of patients who had upgraded blinded biopsy and laboratory results and went on to require and receive radiation therapy and/or surgery. The new results also indicated that the NX-1207 treated patients had 67% less progression to surgery and/or radiotherapy compared to controls (p=.008) for all reasons (including elective surgery and/or radiotherapy with no biopsy or laboratory upgrades).

146 patients were enrolled in the NX03-0040 Phase 2 U.S. trial and either randomized to one of two doses of NX-1207 (2.5 mg or 15 mg) or to active surveillance. The drug was injected into the area of the prostate where the cancer was detected and repeat biopsies were then performed on all patients, drug treated and controls. The patients in the active surveillance group in the study who were eligible could elect crossover drug treatment after their first follow-up rebiopsy. Follow-up studies are being conducted of all consenting patients in the study to continue to monitor outcome and safety data.

These new findings extend the previously reported study results which showed that patients with NX-1207 treatment after 2 months had less clinical progression and significantly less Gleason grade progression, lower average PSA levels, lower numbers of biopsy cores showing greater malignancy, and lower total volume of more malignant cancer compared to controls.

To date, NX-1207 has had an excellent safety profile as both a treatment for benign prostatic hyperplasia (BPH) and localized low-risk prostate cancer. In the current trial, a new high dose of drug (15 mg) was safely used without drug-related adverse effects. NX-1207 has shown safety in repeat injection studies (NX02-0020 and NX02-0022). The drug does not lead to immune responses such as antibody formation which can cause significant drug toxicity and/or limit usage to single treatments due to drug neutralizing effects.

Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. An estimated 233,000 cases will be newly diagnosed in the U.S. in 2014 with approximately 50% of them being initially considered low risk.

NX-1207 is in Phase 3 development in the US and Europe for benign prostatic hyperplasia (BPH) also referred to as prostate enlargement, a common condition of middle-aged and elderly men affecting up to half of men over the age of 50. The Company's European partner for BPH is Recordati S.p.A.





Also Wednesday:






Abiomed Inc. (Nasdaq:ABMD)
, a leading provider of breakthrough heart support technologies, announced that data from RECOVER RIGHT, an Investigational Device Exemption (IDE) study of the Impella RP™ (Right Peripheral) System, will be released during the scientific sessions at the Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) 2014 scientific meeting.

Amarantus Bioscience Holdings, Inc.(OTCQB:AMBS)
, a biotechnology company focused on the development of diagnostic and therapeutic interventions for Alzheimer's disease, Parkinson's disease and orphan ophthalmological disorders, today announced that Dr. Roman Urfer, Chief Development Officer at NeuroAssets Sarl, will be presenting efficacy data for MANF in an undisclosed orphan ocular indication at Targeting Ocular Disorders 2014.

Analogic Corporation (Nasdaq:ALOG)
, enabling the world's medical imaging and aviation security technology, today announced the launch of its new bk3000™ ultrasound system, the newest addition to its industry-leading family of ultrasound products.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
, today announced that management will participate in the J.P. Morgan All Stars Conference on September 16th and in the Bank of America Merrill Lynch Global Healthcare Conference on September 17th, both in London.

Cancer Genetics, Inc. (Nasdaq:CGIX)
, an emerging leader in DNA-based cancer diagnostics, announced today that Panna Sharma will present at the Aegis Healthcare and Technology Conference on Thursday, September 11, 2014 at 8:30 am Pacific Daylight Time (11:30 am EDT).

Cellular Biomedicine Group Inc. (Nasdaq:CBMG)
, a biomedicine firm engaged in the development of new treatments for degenerative and cancerous diseases, today announced the completion of the twelve-month follow-up of patients from the Phase I/IIa trial, which evaluates the safety and efficacy of the Company's proprietary adipose-derived mesenchymal precursor cell (haMPC)-based therapy ReJoinTM for Knee Osteoarthritis (KOA).

Cesca Therapeutics Inc. (Nasdaq:KOOL),
an autologous cell-based regenerative medicine company, announced today it will present at the Aegis Healthcare & Technology Conference on Friday, September 12, 2014 at the Encore at the Wynn Las Vegas.

CONMED Corporation (Nasdaq:CNMD)
today announced that, based on the preliminary vote count provided by its proxy solicitor following the Company's 2014 Annual Meeting, shareholders have elected all eight of CONMED's director nominees: Brian Concannon, Charles Farkas, Jo Ann Golden, Curt Hartman, Dirk Kuyper, Jerome Lande, Stephen Mandia and Mark Tryniski.

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
, a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, announced that an abstract highlighting the therapeutic potential of CYC065, the Company's novel, orally available, second generation cyclin-dependent kinase (CDK) inhibitor, in acute myeloid leukaemia (AML) and mixed-lineage leukaemia (MLL), has been selected for presentation at the Society of Hematologic Oncology (SOHO) annual meeting, taking place September 17-20, 2014 at the Hilton Americas Hotel in Houston, Texas.

Galectin Therapeutics Inc. (Nasdaq:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced the Company will present at the Aegis Capital Corporation 2014 Healthcare and Technology Conference in Las Vegas, Nev., on Friday, September 12, 2014 at 1 p.m. Pacific Daylight Time.

Hemispherx Biopharma, Inc. (NYSE:HEB)
, announced that it expanded its Collaborative Research Agreement to test Alferon®, the only multi-species, natural alpha interferon (IFN) commercially approved in the U.S. and Ampligen®, an experimental drug, to be evaluated against the deadly Ebola virus also under the DEA (Data Exchange Agreement) Annex for Medical Preparedness and Bio-Defense Agreement between the Swiss Surgeon General and the US Department of Defense.

IPC The Hospitalist Company, Inc. (Nasdaq:IPCM), a leading national hospital medicine and post-acute physician group practice company, today announced that Adam Singer, M.D., chairman and chief executive officer, and Jeff Taylor, president and chief operating officer, are scheduled to host investor meetings at the 5th Annual Credit Suisse Small & Mid Cap Conference at the Waldorf Astoria New York in New York City on Wednesday, Sept. 17.

LeMaitre Vascular, Inc. (Nasdaq:LMAT)
, a provider of peripheral vascular devices and implants, announced today that it has opened an office in Shanghai, China.

LifeVantage Corporation (Nasdaq:LFVN)
, a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, today reported financial results for its fourth quarter and full fiscal year ended June 30, 2014.

Medgenics, Inc. (NYSE MKT:MDGN)
, the developer of a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced the appointment of Scott Applebaum as Chief Legal Officer.

Nature's Sunshine Products, Inc. (Nasdaq:NATR)
, a leading natural health and wellness company engaged in the manufacture and direct sale of premium-quality nutritional and personal care products, today announced that Sang Geon Kim, Ph.D. has joined Nature's Sunshine Products' ("NSP") Medical and Scientific Advisory Board.

Nymox Pharmaceutical Corporation (Nasdaq:NYMX)
announced today new positive outcome results from the Company's ongoing prospective NX03-0040 trial of NX-1207 for the treatment of low grade localized prostate cancer.

Oculus Innovative Sciences, Inc. (Nasdaq:OCLS)
, a global healthcare company that designs, manufactures and markets prescription and non-prescription products in 33 countries, today introduced Regenacyn™ Advanced Scar Management Hydrogel into the U.S. over-the-counter market.

The Centers for Disease Control and Prevention (CDC) and Premier, Inc. (Nasdaq:PINC) released new research on the widespread use of unnecessary and duplicative antibiotics in U.S. hospitals, which could have led to an estimated $163 million in excess costs.

Management of QED Connect Inc. (OTC Pink:QEDN) today released a video for its wholly owned subsidiary, Emerald Med Farms Inc..

Receptos, Inc. (Nasdaq:RCPT)
, a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today announced that data from the Phase 2 portion of RADIANCE, the Company's Phase 2/3 trial of RPC1063 in Relapsing Multiple Sclerosis (RMS), will be reviewed in a late breaker oral podium presentation at MS Boston on September 13, 2014.

SANUWAVE Health, Inc. (OTCQB:SNWV)
today announced that the independent Data Monitoring Committee (DMC) has performed an interim analysis on the efficacy results for the first 90 patients in the Phase III supplemental clinical trial using the dermaPACE® for treating diabetic foot ulcers.

Seattle Genetics, Inc.(Nasdaq:SGEN) 
and Genmab A/S (Copenhagen:GEN) today announced that the companies have entered into an additional antibody-drug conjugate (ADC) collaboration.

The Spectranetics Corporation (Nasdaq:SPNC)
today announced that data from EXCITE ISR will be presented as a late-breaking clinical trial at the 26th Transcatheter Cardiovascular Therapeutics (TCT) conference taking place in Washington, D.C., September 13-17, 2014.



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